Practice Exam Questions Flashcards
At the month-3 visit of a Phase III double-blind trial, the subject informs the CRC that he was seen in the emergency department for an anaphylactic reaction. The subject states, “The doctor told me I was very lucky. I might have died.” Having received this information, the MOST appropriate sequence of action is to inform the
PI, sponsor, and IRB.IEC
IN THAT ORDER
A subject is upset and wants to know whom she should contact regarding her rights as a research subject. The CRC should tell her to contact the
A. PI
B. regulatory authority
C. risk management department
D. individual listed in the ICF
D. individual listed on the ICF
While it might be the PI, this reference includes the elements of the informed consent that should be included. Section (q) states that the person(s) to contact for further information regarding the trial and the rights of trial subjects, and specifically who to contact in the event of trial-related injury, should be included. A, B, and C are not the best answer. The purpose of the question is to ensure the candidate knows that this is referred to in the ICF.
The trough blood level for a once-daily drug should be drawn how long after the last dose?
A. immediately
B. 4 hours
C. 12 hours
D. 24 hours
D. 24 hours
Definition of trough (lowest serum concentration level of a drug). This would be defined in the IB.
The trough level should be measured just before the administration of the next dose.
A CRC has received three subject complaints of localized infection at the venipuncture site. The CRC queries the phlebotomist and discovers that when the first stick is unsuccessful, any additional sticks are done with the same needle. This is in violation of the site’s SOPs. Which of the following actions should the CRC take?
- Suggest review of proper specimen collection for the phlebotomist.
- Document and report the findings.
- Inform the IRB/IEC of the situation and the corrective action.
- Report the incidents to the IDMC/DSMB.
1 and 2 only
[1] CORRECT E6 1.55 discusses that SOPs are written detailed instructions to achieve uniformity of the performance of a specific function. We know from the stem that the phlebotomist isn’t following site SOPs, so it would be correct to review the procedures. [2] CORRECT E6 4.2.4 discusses that the investigator should ensure that all persons assisting with the trial are adequately informed on the duties and functions. [3] WRONG There is no specific requirement to report it to the IRB/IEC (though each IRB might have instructions like that, it’s not across the board). [4] WRONG There is no guidance to report it to the DSMB.
All of the following are regulatory documents EXCEPT
A. informed consent
B. protocol signature page
C. laboratory certification
D. confidentiality agreement
D. confidentiality agreement
Regulatory documents demonstrate the compliance of the Investigator, Sponsor and IRB/IEC with the standards of Good Clinical Practice and with all applicable regulatory requirements [A] WRONG: the informed consent is a regulatory document because it is a process by which a subject confirms willingness to participate in a trial . This document has to be approved by the IRB/IEC. [B] WRONG: the protocol signature page is signed by the PI and sponsor to document agreement to the protocol and amendments [C] WRONG: a laboratory certification documents competence of the facility to perform required tests and support reliability of results. [D] CORRECT: a confidentiality agreement is a nondisclosure contract entered into by the sponsor and the investigator and is not governed by regulatory authorities
A CRA is conducting a close-out visit at a site to review the regulatory documents. The CRC has prepared the following documents to be filed and/or sent to the sponsor: treatment decoding documentation, drug accountability log, subject identification code list, documentation of IP destruction, and final report to the IRB/IEC. Which of the following actions should the CRC perform?
- Send the treatment decoding documentation to the sponsor.
- Remove the subject identification code list from the material to be sent to the sponsor.
- Send copies of the IP destruction forms to the sponsor.
- Remove the drug accountability log from the material to be sent to the sponsor.
1, 2, and 3
- Correct-the Sponsor retains the Decoding Documentation 2. Correct-the Subject ID Code list is to be kept at the site in a confidential manner 3. Correct-documentation of the destruction is kept at the site [if the IP was destroyed at the site] and with the sponsor. 4. Wrong-documentation of IP accountability is kept at both the site and with the sponsor [A] CORRECT: 1,2,and 3 are all correct answers [B] WRONG: 4 is incorrect [C] WRONG: 4 is incorrect [D] WRONG: 4 is incorrect
Which of the following is a liver function test?
A. TSH
B. LDH
C. BUN
D. Hct
B. LDH
A] WRONG - Thyroid Stimulating Hormone – test used to assess the function of the thyroid gland [B] CORRECT - Lactate Dehydrogenase – test used to check for damage to the tissue of the heart, liver, kidney, muscles, brain, blood cells, and lungs. [C] WRONG - Blood Urea Nitrogen – kidney function test [D] WRONG - Hematocrit - blood test measuring the percentage of the volume of whole blood that is made up of red blood cells. To be certified, candidates are expected to have general knowledge of laboratory terminology, tests and procedures.
According to ICH Guidelines, the source document should contain which of the following information regarding informed consent?
A. time the consent form was signed by the subject
B. date the PI and subject signed the consent form
C. date and tiem the consent form was signed by the witness
D. evidence that the consent form was signed prior to trial-related procedures
D. evidence that the consent form was signed prior to trial-related procedures
A] WRONG This is not covered in ICH. Time signed is not required (although it may be per the IRB, it is not required per ICH). [B] WRONG The PI is not required to sign the form, it’s the person conducting the consent. [C] WRONG A witness may or may not be required. [D] CORRECT E6 4.8.8 says that the ICF must be completed prior to subject’s participation.
A clinical trial is being conducted for hormone replacement. The trial includes a diary. Which of the following would be considered an objective parameter?
A. modd swings
B. breast tenderness
C. severity of hot flashes
D. episodes of vaginal bleeding
D. epsidoes of vaginal bleeding
An objective symptom can be measured or observed and is not dependent on, or influenced by, the subject’s feelings or opinions [A] WRONG-mood swings are measured by the subject’s opinion [B] WRONG-breast tenderness is measured by the subject’s opinion [C] WRONG-severity of hot flashes is measured by the subject’s opinion [D] CORRECT-vaginal bleeding is observed
A subject presents at a site with her husband, after pre-qualifying on a phone screen. She states that she is legally blind and cannot read the ICF. A Braille ICF is not available. This subject is able to sign her name if her hand is guided to the signature line. Which of the following is the BEST course of action to obtain legal consent for this subject?
A. The subject and an impartial witness can sign the ICF after it is read to them and she verbally states her understanding.
B. Her husband can sign the ICF for her after it has been read to the subject and she verbally states her understanding.
C. The subject does not qualify as she is unable to read the ICF herself and a Braille consent form is not available.
D. An investigator must co-sign the ICF after it has been read to the subject and she verbally states her understanding and has signed the ICF.
A. The subject and an impartial witness can sign the ICF after it is read to them and she verbally states her understanding.
[A] CORRECT E6 4.8.9 discusses, specifically, the need for an impartial witness when a subject is unable to read (there wouldn’t necessarily be a LAR in this case). The impartial witness should be present for the entire discussion. They are not just witnessing a signature. Reference E6 1.26 further clarifies who an impartial witness can be and it would not include the spouse, so the husband wouldn’t be appropriate to sign. [B] WRONG There is no indication that the husband is the LAR [C] WRONG Unless vision is an inclusion criteria, there is nothing to indicate that she does not qualify due to being legally blind [D] WRONG The regulations do not support this. Only the subject (or LAR) and person conducting the consent must sign. An impartial witness is used in some cases as in the reference.
Creat
assesses kidney function, usually ordered with BUN
A small biotech company is investigating the anti-tumoral potential of scorpion toxin in high grade recurrent brain tumors. After animal trials have been completed, the first trial in humans would MOST likely involve
- healthy volunteers.
- pharmacokinetic analysis.
- placebo control.
- dose escalation.
D. 2 and 4 only
1] WRONG Phase I trials may be done in healthy volunteers AND certain types of patients (they are NOT always limited to healthy volunteers). [2] CORRECT: Phase I trials are primarily involved with PK sampling [3] WRONG: Phase I may or may not use a placebo control; however it would not be ethical in a recurrent brain tumor study. [4] CORRECT: Dose escalations are primarily done in Phase I trials. Option D is the only choice with both of the correct statements.
A competent adult subject signs a consent form with an “X” and indicates approval. Which of the following is the BEST action for the CRC to take?
A. Have the consent form notarized.
B. Exclude the subject from the trial.
C. Document why the subject signed with an “X”
D. Have the legal guardian sign the informed consent form.
C. Document why the subject signed with an X”
[A] WRONG There is no mention in the guidelines for notarization [B] WRONG There is no indication that this subject should be excluded from the trial (protocol specific) [C] CORRECT The reference E6 4.8.8 talks about the subject signing and personally dating the ICF by the subject (or LAR). In this case, the subject is competent but can’t write their name. The best course of action is to have the subject sign as best as they can and then document that the “X” was made by the subject. [D] WRONG There is generally no LAR for a competent individual.
In addition to obtaining a signed informed consent form, which of the following should be documented in the research record?
- the time and date that the procedures will be performed
- that the subject’s questions were answered
- the names of people present during the consent process
- that no trial procedures were performed prior to consenting
C. 2 and 4 only
1] and [3] WRONG these are not listed in the references. [2] and [4] CORRECT these are listed in the E6 reference. E6 4.8.7 speaks to answering a subject’s questions. E6 4.8.8 talks about the ICF needing to be signed and dated by the subject (etc.) prior to a subject’s participation.
A sponsor has supplied all sites with digital thermometers for a vaccine trial. At one site, the CRC notices that 10 of 30 subjects have recorded consistently low temperature readings in their diaries for the first 7 days of the trial. Upon review with the subjects, there were no related complaints. Which of the following should be the CRC’s FIRST action?
A. Notify the sponsor.
B. Contact the manufacturer
C. Inform the remaining 20 subjects.
D. Replace existing thermometers with an alternate model.
A. Notify the sponsor.
[A] CORRECT- the sponsor is responsible for maintaining quality assurance and control [B] WRONG- the sponsor would contact the manufacturer [C] WRONG- the CRC would inform the remaining subjects if instructed to do so by the sponsor [D] WRONG-the sponsor is responsible for supplying the equipment for this trial
